In the span of just three days, Governor Doug Ducey and Arizona lawmakers reviewed, adopted and signed major legislation related to opioids and pain management. Patients Rising joined with other advocacy organizations in calling for amendments that would protect patient access to necessary treatments.
Governor Doug Ducey recently signed major legislation that would change the way that patients access pain management treatments, including opioids.
The Arizona opioid legislation was approved “at breakneck speed” during a special legislative session. In the span of just three days, state lawmakers reviewed, amended and approved the legislation, and Gov. Ducey signed the bill into law.
Patients Rising joined with other advocacy organizations in calling for amendments to ensure that this legislation addresses these public health challenges in a way that puts patients first. Patients in Arizona support reform legislation that will preserve patient access to necessary pain management treatments and address the growing problem of drug abuse.
Here are ways that Arizona’s lawmakers can strike the right balance: to protect patients living in chronic pain and tackle the problem of drug abuse.
This provision requires that the Board of Supervisors from each county shall establish at least one location in the county where a person may drop off any legal or illegal drug or substance and drug paraphernalia and receive a referral to a substance abuse treatment facility.
We strongly support this provision as a step in the right direction; however, we are concerned that the requirement for just one drop off location, coupled with the very large geographic areas covered by Arizona’s counties, mean that these drop off locations will remain inaccessible to many of the state’s citizens.
This provision prohibits a Good Samaritan who has sought medical help related to an overdose from being charged or prosecuted for possession of a controlled substance if the evidence for the charge or prosecution of the drug-related crime resulted solely from seeking medical assistance.
We strongly support this provision as an important step in solving the current problem of unintended overdose deaths resulting from the use of opioid pain relievers and illicit opioid drugs. However, this provision could be made much more effective if, in addition to being exempt from being “charged” or “prosecuted”, Good Samaritans also received protection from being “arrested”—people do not call 911 if they fear arrest, and the whole purpose of this provision is to ensure that they do call 911 so that the overdose victim can receive medical care.
These provisions require health professionals who are authorized to prescribe Schedule II controlled substances, as well as medical students who are enrolled in a public or private medical school in this state, to take at least three hours of opioid-related clinical education (for health professionals, that is three hours each renewal cycle).
We strongly agree that additional pain education is needed for medical students and health professionals, and we are supportive of a pain-related mandate. However, we often say in regard to opioids: when all you have is a hammer, every problem looks like a nail. By this, we mean that when we continually teach only opioids to our medical students, they see pain as something that must be treated with opioids and that is inextricably linked to opioids. However, pain management often requires a multimodal approach, bringing together all appropriate therapeutic approaches to reduce pain and achieve optimal health and healing. If health care providers are to be expected to use a multimodal approach to pain management, we must teach them how to use more than just opioids to treat pain and when other treatments are indicated.
In order to encourage optimal pain management practices while decreasing the occurrence of addiction and overdose, we suggest a more focused approach to designing the curriculum. As advocates of optimal health care practices and policies, as well as a provider of continuing medical education, we strongly recommend that you consider requiring education in the following three areas:
Finally, we strongly urge you to extend the pain-related education requirement beyond just those students enrolled in medical schools. Again, because pain is best treated through a multimodal, multidisciplinary approach, it is imperative that other potential prescribers, including Nurse Practitioner students, Physician Assistant students, and Dental students, all receive adequate pain and opioid education.
Under these provisions, the definitions of “health care service”, “medically necessary”, and “medical necessity” do not include treatments that are experimental, investigational, or off label.
This is of serious concern to us, as excluding these treatments from these definitions will severely gut the provision of many services. Many medications are used, appropriately and effectively, off-label in the course of treating pain. These provisions would actually reduce the number of non-opioid pain treatments available to prescribers and patients, as it would prevent gabapentin and other anticonvulsants from being used to treat neuropathic pain. At a time when health care providers are looking for ways to treat pain without using opioid analgesics, we should not be making it more difficult for patients to access non-opioid medications that are safe and effective for treating their pain conditions.
This provision states that a health care services plan must allow at least one modality of medically assisted treatment (MAT) to be available without prior authorization.
We strongly support increased coverage for MAT. However, there are three forms of MAT that could be chosen, depending on the patient’s needs and clinical judgment. In the face of an opioid overdose epidemic, patients should have access to whichever MAT treatment their health care provider believes is best indicated for their particular situation. Therefore, this section should require that all MAT options are available without prior authorization.
This provision states that beginning January 1, 2020, the health care services plan or its utilization review agent shall accept prior authorization requests through a secure electronic transmission.
We strongly support the requirement that health care services plans accept prior authorization requests electronically. However, given that this has already been implemented in many other states, delaying this requirement until January 1, 2020 seems unnecessary. Insurers should be able to get these systems up and running far quicker than that, and the 2020 date will only serve to hinder patient care for an unnecessarily long period of time.
This provision requires that requests for prior authorization must be approved or denied within 14 days under normal circumstances and within 5 days for urgent care situations.
We strongly urge that this provision be amended, as these timelines are unjustifiably long and have the potential to cause serious harm, and even death, to patients.
Prior authorization is a case management tool used by third-party payers to control costs and help assure the use of safe and effective tests and treatments. It can be used to permit or limit access to diagnostic tests, procedures, provider visits, or medications. At its best, prior authorization helps protect patients from unnecessary, ineffective, or unsafe medical services; at its worst, the process becomes a significant barrier for patients in obtaining the care their health care provider believes to be best. Oftentimes, response times from payers can be so lengthy that many providers and patients become discouraged and fail to follow the process through to the end; many requests are initially denied; and the amount of time (and therefore, cost) invested by the health care provider and his or her staff can be substantial. In some cases, the process can cause patients’ medical conditions to deteriorate, increasing the need for more expensive and invasive medical treatment in the future.
In recent years, nearly every state that has considered this issue has reduced maximum response times related to prior authorizations to 24 hours in emergency/urgent circumstances and 72 hours under normal circumstances. In fact, when Michigan updated their own prior authorization statute in 2016 with the passage of MI HB 4935, they changed from an older law that set timelines at 72 hours and 15 days to a new law that follows the national trend of 24 hours and 72 hours for urgent and non-urgent requests, respectively. Given that most contemporary prior authorization requests are processed electronically, there is no longer a need to give insurers weeks to process requests, particularly when patient lives are at stake.
Under this provision, for a prior authorization request related to a chronic pain condition, the health care services plan or its utilization review agent may request that the provider submit information to the health care services plan or its utilization review agent indicating that the enrollee’s chronic pain condition has not changed and that the continuation of the treatment is not negatively impacting the enrollee’s health. If the provider does not respond within five business days after the date on which the request was received, the health care services plan or its utilization review agent may terminate the prior authorization.
We find this entire provision confusing and problematic. It is unreasonable to give the health care provider only five days to respond before issuing a termination of prior authorization. Unlike insurers, who have large staffs capable of handling quick turnaround of these sorts of requests, most health clinics will struggle to meet the five day turnaround under the best of times—and will find it impossible when providers are out off the office on vacation, for example.
It is unclear from the wording of this provision as to whether a health care provider must respond within five days of the issuance of the letter or within five days of receiving the letter. It is also unclear from this provision when insurers may ask health care providers for this information. Do they ask for this information prior to granting a prior authorization request? If so, we are confused as to how they would “terminate” a prior authorization that hasn’t already been in effect. And further, if the prior authorization has already been in effect, does that mean that insurers may ask a health care provider for this certification at any time? And if so, wouldn’t that allow an insurer to repeatedly ask health care providers for this type of information in the hopes that they won’t receive a response, thus allowing them to terminate the prior authorization purely due to lack of response? None of this would be in the best interest of the patient or health care provider.
Finally, and extremely confusingly, (C)(2) states that “This section does not apply to: […] any opioid or benzodiazepine or other Schedule I or II controlled substance.” We do not understand how a section related to pain medications does not apply to opioids—was this an error in drafting? Further, Schedule I drugs are illegal and so should not be listed in this section; not all opioids are listed in Schedule II; and, benzodiazepines are not listed in Schedule II. We believe this provision needs to be redrafted for clarity.
Collectively, these provisions make it unprofessional conduct for a health care provider to dispense a Schedule II controlled substance for pain management.
We are extremely concerned with these provisions, as a blanket prohibition on health care providers dispensing Schedule II medications has the potential to severely affect rural populations who lack access to nearby pharmacies. While we understand the desire to keep dispensing limited to pharmacies, we would urge you to consider some sort of middle step that involves increased monitoring of controlled substance dispensing from practices. For instance, if the Board of Pharmacy receives reports of controlled substances sold to individual practices, they can later follow up with those practices to see what is happening with the medications. There could also be other requirements, such as periodic inventories, logs of medications dispensed, etc.
We are also concerned that targeting “Schedule II controlled substances for pain management” isn’t quite the most accurate target for these provisions. Rather, the provisions should apply to all opioid analgesics in Schedule II, but should exempt any opioids used for the treatment of a substance use disorder.
This provision limits initial prescriptions for Schedule II controlled substances for pain management to no more than a five-day supply, with exceptions.
We appreciate the thoughtful exceptions that have been included within this provision, as they will help to ensure that many patients with legitimate medical needs will not be burdened with having to make additional trips to their health care provider beyond what is necessary. However, most states that have considered this issue in recent months and years have settled on a seven-day limit rather than a five-day limit, which helps to ensure that (1) patients have enough medication until they can secure a follow-up appointment (availability is limited, particularly in pain management clinics), and (2) the patient has had sufficient time to adjust to a medication to determine efficacy but not so much time as to unnecessarily expose the patient to increased risk of addiction. Further, most states have agreed, as do we, that these limitations must contain an exception for those with a chronic pain diagnosis.
These duration limits are introduced by legislatures quite regularly at this time, with most having agreed upon language that we support (originally passed in Massachusetts) very similar to the following:
A practitioner may not issue more than a seven-day supply of an opioid.
If a practitioner issues a prescription for more than a seven-day supply of an opioid, the practitioner must:
This section does not apply to the issuance of prescriptions for the treatment of substance abuse or opioid dependence.
This provision states that a health professional may not issue a new prescription order for a Schedule II controlled substance for pain management that exceeds 90 morphine milligram equivalent (MME) per day, with exceptions.
Given the selection of 90 MME/day as a limit, we assume this decision was developed in reaction to the recently released CDC Guideline for Prescribing Opioids for Chronic Pain. In its guideline, the CDC recommends: Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. However, it’s is vital to note that the CDC never states that 90 MME/day is a maximum dosage limit. What’s more, the CDC has been emphatic, both within their guideline and in related press, that “the recommendations in the guideline are voluntary, rather than prescriptive standards.” And further, it is “based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.” Finally, the guideline was intended to apply only to primary care providers treating people with chronic pain, excepting those receiving palliative and end-of-life care. This guideline was intended to give clinicians recommendations which they would then apply to the individual patient they are treating. In contrast, this bill would severely limit a prescriber’s ability to treat each individual patient according to their respective conditions and biological factors. What’s more, it would restrict access to one of the primary forms of pain management treatment that is reimbursed by insurers while doing absolutely nothing to increase access to, and insurance coverage of, alternative forms of pain management, leaving patients without options for care.
Under the provisions of this bill, in order for a health care provider to exceed 90 MME/day when treating a pain condition, a specialist who is board-certified in pain would first have to be consulted. This is problematic, as pain management specialists commonly have so many patients that the waiting time for a new patient appointment is typically weeks to months. Increasing the volume of consultations substantially, as this legislation anticipates, will exacerbate that problem. For the person with pain who is being referred to the specialist, this means they will need to wait for long periods of time, with uncontrolled pain, before they are allowed to try a higher dose of opioids. Further, it is unlikely that the supply of board certified pain specialists would meet the demand in rural areas. In those areas, people may not be able to access the specialty care required to enact the exception due to geographic barriers, resulting in undertreatment of their pain and leaving them to facing a greatly reduced quality of life.
We strongly recommend that this legislation clearly states that the dosage limits do not apply to individuals whose chronic pain is being managed by a health care provider.
Alternatively, we recommend that, to ensure an adequate supply of pain specialists, the legislation not be limited to board-certified pain specialists. Rather, to increase the number health care providers that qualify as pain specialists under this statute, we suggest that you accept the following qualifications in addition to board certification:
This provision defines a pain management clinic to mean “a health care institution or a private office or clinic of a health care provider […] in which a majority of the facility’s patients in any month are prescribed opioids, benzodiazepines, barbiturates or carisoprodol, not including suboxone, for pain management for more than 90 days in a twelve-month period.”
Our concern with this provision is small, but important—we do not understand why Suboxone is the only excluded drug. Rather, all medications being used for treatment of a substance use disorder should be excluded. We suggest changing the definition so that it says:
“[…] a health care institution or a private office or clinic of a health care provider […] in which a majority of the facility’s patients in any month are prescribed opioids, benzodiazepines, barbiturates or carisoprodol for pain management for more than 90 days in a twelve-month period. Drugs prescribed to treat a substance use disorder shall not be included when making this calculation.”
This provision also requires that the pain management clinic have a medical director who is a physician licensed in this state under an unrestricted and unencumbered license.
While we strongly support setting requirements for who may or may not operate a pain management clinic, we do not believe it is necessary for the health care provider to be licensed in Arizona. However, we strongly recommend that the medical director of a pain management clinic qualify as a pain management specialist, as we outlined above in our discussion of 32-3248.01. Most states that have considered this issue have come up with three main requirements that the owner and/or medical director of a pain management clinic must meet:
This provision requires the container of a Schedule II medication dispensed for pain to have a red cap and a warning label prescribed by the Board about potential addiction.
While we are not opposed to conveying important addiction-related information to patients, we are very concerned about the red cap for two reasons: (1) the red cap is incredibly stigmatizing to those with pain; and (2) the red cap will make the bottle an eye-catching and easy target for unsavory characters.
We suggest, as an alternative to the red cap plan, that the Arizona State Board of Pharmacy be directed to develop a standard educational handout to accompany all Schedule II medications dispensed for pain that contains information on potential addiction, safe use, storage, and disposal of medications.
This provision deletes: “Except as required pursuant to subsection B of this section, the board shall provide this information only if the requesting board states in writing that the information is necessary for an open investigation or complaint.”
We strongly oppose this deletion. We are in complete support of medical practitioner regulatory boards obtaining prescription monitoring data if they are engaged in an active and specific investigation of a specific practitioner and the record being requested is reasonably related to that investigation. The current law allows just that while also ensuring that one’s highly personal medical history is treated as the highly private and personal information that it is. If the proposed language is deleted, it will allow these boards to go on “fishing expeditions” in which they search through private medical information with no reason to believe that the private medical information contains anything of relevance to a pending investigation.